Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) - Hybrid
AbbVie84500 - 162000
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Job Description
📋 Description Manage, compile, and author CMC sections of marketed product variations with minimal management Update simple CMC documents independently. Partner with RA CMC Project Leads to create content plans and timelines. Collaborate with functional groups to ensure file-ability and acceptance of CMC sections. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and Independently run team reviews and management reviews of submission documents. 🎯 Requirements Bachelor's degree in Chemical and/or Biological Sciences or relevant discipline 4 years pharma or industry experience; 1-2 years in quality systems or cross-functional PM 5 years pharma experience including regulatory affairs or Discovery/R&D/Manufacturing Strong knowledge of manufacturing unit operations or CTD structure Excellent oral and written communication; able to collaborate globally Experience with electronic document management systems 🎁 Benefits AbbVie comprehensive benefits package including PTO, medical/dental/vision, and 401(k) Eligible to participate in short-term incentive programs Competitive compensation with potential for adjustment based on location and performance